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A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545543
Recruitment Status : Completed
First Posted : September 10, 2015
Results First Posted : April 18, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Seqirus

Brief Summary:
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: Seqirus QIV Biological: Comparator QIV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Multicenter, Observer-Blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population 5 Through 17 Years of Age
Study Start Date : September 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Seqirus Quadrivalent Inactivated Influenza Vaccine
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Biological: Seqirus QIV

Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.

The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.


Active Comparator: Comparator Quadrivalent Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Biological: Comparator QIV

The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.

The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.

Other Name: Fluarix Quadrivalent




Primary Outcome Measures :
  1. The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. [ Time Frame: 28 days after last vaccination. ]
    Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.

  2. The Difference in Seroconversion Rate (SCR) for Each Virus Strain. [ Time Frame: 28 days after last vaccination. ]
    Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.


Secondary Outcome Measures :
  1. Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. [ Time Frame: 7 days after each vaccination. ]
    Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose

  2. Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs). [ Time Frame: 7 days after each vaccination. ]
    Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose

  3. Safety Endpoint: The Frequency of Cellulitis-like Reaction. [ Time Frame: 28 days after each vaccination. ]
    Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose

  4. Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs). [ Time Frame: 28 days after each vaccination. ]
    Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose

  5. Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). [ Time Frame: 180 days after the last vaccination dose. ]
    Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.

  6. Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit) [ Time Frame: 28 days after last vaccination. ]

    The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:

    - Geometric mean of HI titers prevaccination & postvaccination


  7. Immunogenicity Endpoint: Seroconversion Rate (SCR) [ Time Frame: 28 days after last vaccination. ]

    The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:

    - SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer


  8. Immunogenicity Endpoint: Seroprotection Rate [ Time Frame: 28 days after last vaccination. ]

    The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:

    - The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit


  9. Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) [ Time Frame: 28 days after last vaccination. ]

    The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:

    - Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females 5 through 17 years of age on the day of first study vaccination.
  • Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws. Participant assent will also be obtained if required.
  • If applicable, females of childbearing potential (ie, ovulating, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen until at least 28 days after the last Study Vaccine. Females of childbearing potential must return a negative urine pregnancy test result, prior to any vaccination dose with the Study Vaccine.

Exclusion Criteria:

  • History of allergic reactions to egg proteins or any components of the Study Vaccines.
  • History of serious adverse reactions to any influenza vaccines.
  • History of Guillain-Barré syndrome or other demyelinating disease.
  • History of licensed or investigational influenza vaccination in the last 6 months.
  • Clinical signs of active infection and/or an oral temperature of ≥ 100°F (37.8°C) on the day of planned Study Vaccine administration or within 48 hours preceding vaccination.
  • Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable (such as illness exacerbations) within the preceding 30 days.
  • History of any seizures, with the exception of a single febrile seizure.
  • Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C.
  • Known or suspected congenital or acquired immunosuppressive conditions.
  • Current or recent immunosuppressive or immunomodulatory therapy, as follows:

    • Chronic or long-term systemic corticosteroids: ≥ 0.125 mg/kg/day of oral prednisolone or equivalent daily;
    • Sporadic systemic corticosteroids: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination;
    • Antineoplastic chemotherapy or radiation therapy within the 6 months preceding vaccination.

Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to administration of the Study Vaccine or throughout the study are acceptable.

  • Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study.
  • Participation in a clinical trial or use of an investigational compound within 28 days prior to the first dose of Study Vaccine, or within 28 days after receiving the final indicated dose of Study Vaccine, or plans to enter a study during this period.
  • Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
  • Pregnant or lactating females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545543


Locations
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Sponsors and Collaborators
Seqirus
Investigators
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Study Director: Clinical Development Physician Seqirus Seqirus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02545543    
Other Study ID Numbers: CSLCT-QIV-13-02
First Posted: September 10, 2015    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: May 23, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases